The chemical filter, in use in Europe since 1999, is the first sunscreen active approved under a streamlined monograph reform that has so far cleared only this one ingredient.
The U.S. Food and Drug Administration on Tuesday approved bemotrizinol, a chemical sunscreen filter that blocks both UVA and UVB rays and is already in widespread use in Europe, ending a more than two-decade wait and validating a 2020 reform meant to clear a backlog of new ultraviolet filters stuck in regulatory limbo.
The agency called bemotrizinol the first new sunscreen active cleared for the U.S. market in more than 25 years, according to STAT News, which carried the Associated Press wire on the approval. The approval is the first proof point for an expedited process Congress built into law six years ago, when it told the FDA to design a faster mechanism for updating the over-the-counter sunscreen monograph that had effectively frozen new chemical filters out of the U.S. market.
Bemotrizinol was first filed with the FDA in 2005 and has been authorized in Europe since 1999. Its U.S. arrival is regulatory catch-up, not a scientific first. The filter covers both UVA rays, the longer-wavelength ultraviolet that ages skin, and UVB rays, the shorter-wavelength ultraviolet that burns it, in a single molecule, doing what current U.S. chemical sunscreens typically need to be combined to do. It also does not leave the white residue associated with zinc- and titanium-based mineral formulas.
Before bemotrizinol, the last new sunscreen active to win a generally recognized as safe and effective determination in the U.S. dated to the late 1990s. The U.S. sunscreen market has run on a small set of chemical filters approved in the 1970s and 1980s, plus zinc oxide and titanium dioxide. Newer chemical filters that have been used in Europe, Asia, and Australia for years have been waiting in regulatory limbo, the same limbo bemotrizinol was in until this week.
The FDA approved bemotrizinol for adults and children 6 months and older, saying the ingredient met agency standards for UV protection with low irritation and low skin absorption. The agency did not describe the ingredient as risk-free. It drew a defined safety envelope based on its own review.
The 2020 reform, folded into the Coronavirus Aid, Relief, and Economic Security Act and the broader over-the-counter drug monograph overhaul, created a streamlined pathway for adding new sunscreen actives without going through the slow, additive rulemaking the FDA had relied on for decades. The new pathway lets the agency issue administrative orders updating the monograph when ingredients meet modern standards, which is what it did for bemotrizinol on Tuesday.
David Andrews, a senior scientist at the Environmental Working Group, has spent years arguing that the U.S. sunscreen chemistry is outdated compared with Europe, Australia, and Japan, where newer filters have been on shelves for decades, according to STAT News. On Tuesday, his criticism was not that bemotrizinol is unsafe. It was that it should not have taken 21 years and a legislative fix to get here.
Bemotrizinol's U.S. marketer is DSM Nutritional Products, a Dutch ingredient maker, which will sell it domestically under the brand name Parsol Shield. Launch is expected later in 2026. DSM has an 18-month exclusivity period before other manufacturers can use the ingredient in their own formulations, which means the first U.S. products containing bemotrizinol will all carry the Parsol Shield name or be supplied by DSM.
The exclusivity window is also the test period for the FDA's 2020 pathway in the market. If bemotrizinol lands on shelves and is well tolerated, it will harden the case that the streamlined process can clear other ingredients. Several other filters, including some already approved in Europe, remain in the FDA pipeline.
The reform still has more ingredients to clear, and the FDA has not said when it will act on them. The agency's announcement on Tuesday is one administrative order. The 2020 pathway was built to do this repeatedly. Whether it does is the question worth watching.